SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT02092909

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

Phase 1/2 Open-Label, Multiple-dose, Dose-escalation Study to Evaluate the Safety and Tolerability of IMO-8400 in Patients With Relapsed or Refractory Waldenstrom's Macroglobulinemia

Recent reports have identified a specific oncogenic mutation L265P of the MYD88 gene in approximately 90% of the patients with Waldenström's macroglobulinemia. MYD88 is a key linker protein in the signaling pathway of Toll Like Receptors (TLRs) 7, 8, and 9, and IMO-8400 is an oligonucleotide specifically designed to inhibit TLRs 7,8, and 9. The scientific hypothesis for use of IMO-8400 to treat patients with Waldenström's macroglobulinemia depends on the inhibition of mutant MYD88 signaling in the TLR pathway, thereby interrupting the proliferation of cell populations responsible for the propagation of the disease.

NCT02092909 Waldenstrom's Macroglobulinemia
MeSH: Waldenstrom Macroglobulinemia
HPO: Monoclonal immunoglobulin M proteinemia

1 Interventions

Name: IMO-8400

Type: Drug

IMO-8400 at escalating dose levels


Primary Outcomes

Description: Assessment of adverse events, injection site reactions and concomitant medications in escalating dose levels of IMO-8400.

Measure: Safety and tolerability of IMO-8400 in patients with Waldenstrom's Macroglobulinemia

Time: Duration of study

Secondary Outcomes

Description: To assess the treatment effect (clinical activity) of escalating dose levels of IMO-8400 using disease-specific international guidelines for classifying clinical response.

Measure: Assess the treatment effect

Time: Duration of study

Description: To identify an appropriate dose of IMO-8400 for further clinical evaluation.

Measure: Identify an appropriate dose of IMO-8400

Time: Duration of study

Description: To characterize the pharmacokinetics of escalating dose levels of IMO-8400 administered once weekly by SC injection.

Measure: Characterize PK

Time: Duration of study

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 L265P

Phase 1/2 Dose Escalation Study in Patients With Relapsed or Refractory Waldenstrom's Macroglobulinemia Recent reports have identified a specific oncogenic mutation L265P of the MYD88 gene in approximately 90% of the patients with Waldenström's macroglobulinemia. --- L265P ---



HPO Nodes


HPO:
Monoclonal immunoglobulin M proteinemia
Genes 1
MYD88